Market Overview

Algeta results for the third quarter 2012


Not intended for US media

Oslo, Norway, 15 November 2012 - Algeta ASA (OSE: ALGETA), a company focused on the development of novel targeted cancer therapeutics, announces its results for the third quarter 2012.

A presentation of the results in Oslo will be webcast live from 10:00 CET and can be accessed at www.algeta.com/webcast.An international conference call will take place at 14:30 CET/ 08:30 Eastern Time (US). Details of both events are at the end of this announcement.

Andrew Kay, Algeta's President and CEO, said: "Algeta is entering a transformational period where our focus is on the preparations needed for a successful launch of radium-223 dichloride, pending regulatory approvals. We have been working with Bayer to complete the documentation required for the first submissions seeking marketing approval, and we are very pleased to report that these remain on schedule for this year."

Highlights of the third quarter 2012 and significant post period events:

  • Algeta's new commercial production facility for radium-223 dichloride (radium-223, Alpharadin) was completed during the quarter and the three documentation batches required for the CMC[1] sections of the submissions to regulatory authorities have been successfully produced. Stability testing of these batches is now underway. These data analyses are being shared with Bayer for the completion of the regulatory dossiers.

             
            First submissions seeking marketing approval for radium-223 are expected by the end of 2012.

  • In September, the Algeta Group celebrated the official opening of the offices and facilities of Algeta US in Cambridge, MA. Algeta US has already established an experienced oncology management team who will continue to build a highly focused organisation.

Algeta US currently employs 17 people and plans to deliver a phased build-up of resources in anticipation of a US commercial launch, with Bayer, of radium-223, pending approval by FDA.

  • In September, further data from the phase III ALSYMPCA trial of radium-223 in castration-resistant prostate cancer patients with bone metastases was presented in two analyses at the ESMO 2012 Congress. 

             
The first analysis indicated that hematologic safety profiles for patients receiving chemotherapy after radium-223 were similar to those for patients receiving chemotherapy after placebo.

The second analysis indicated that radium-223 was superior to placebo in health-related quality of life (QOL) measures.
             

  • In November, based on the results of the dose escalation (phase I) portion of the BC1-10 trial of radium-223 in combination with docetaxel chemotherapy, the decision was taken, by Algeta and Bayer, to progress to the phase IIa (expanded safety cohort) portion of the study. Enrolment of approximately 45 CRPC patients with symptomatic bone metastases will now begin in eight centers across the US and Europe.
     
  • In August, Algeta disclosed its fourth TTC program to investigate a novel Targeted Thorium Conjugate addressing hematological cancers.
     
  • In November, Algeta further strengthened its R&D capabilities, particularly in chelation and conjugation technologies, with the appointment of Dr Alan Cuthbertson as Senior Vice President, Research and Development. Dr Cuthbertson spent the past 20 years at GE HealthCare at which he held parallel senior roles managing international teams focused on medicinal chemistry and new product discovery and development. He joins the senior management team at Algeta and will lead the R&D department in Oslo, reporting to Thomas Ramdahl, Executive Vice President and Chief Technology Officer.

             

Key financials
 
  • Operating revenue for the third quarter 2012 amounted to NOK 60m compared with NOK 63m in the third quarter in 2011.
  • Core operating expenses[2], which exclude currency effects, interest income and costs directly related to preparation of commercial launch in the US, if approved, for the third quarter 2012 amounted to NOK 74m, compared with NOK 69m in the third quarter 2011.

             

  • Algeta's recognized share of US co-promotion activity expenses for the third quarter of 2012 was NOK 17m.
  • Liquid funds amounted to NOK 426m as of 30 September 2012, compared with NOK 317m at the end of December 2011.

             

The full Third Quarter Report 2012 and accompanying presentation will be available at www.algeta.com in the Investors section from 07:00 CET.

 
Details of presentation and webcast
 

A presentation by Algeta's senior management team to investors, analysts and the press will take place in Oslo at 10:00 CET.

Shippingklubben
Haakon VIIs gate 1
0161 Oslo
Norway.

The presentation will also be webcast live and can be accessed at www.algeta.com/webcast. Questions can be submitted live during the webcast.

Details of international conference call

To participate in the conference call, please dial the appropriate number below five minutes prior to the call:

USA: +1 866 5088 015
UK: +44 203 147 4601
Norway: +47 21 01 09 30
Sweden: +46 850 559 840
Denmark: +45 701 404 50
Switzerland: +41 225 802 964

Participant pin code: 598258#

----

To access the replay, please dial:

USA: +1 866 3056 292
UK: +44 207 750 99 28
Norway: +47 21 01 09 26
Sweden: +46 850 626 949

Conference reference: 275589#

A replay version of the conference call will also be available at www.algeta.com.

###

For further information, please contact

Mike Booth +47 2202 4510
Communications & Corporate Affairs ir@algeta.com
Media enquiries:
Mark Swallow +44 207 638 9571
Citigate Dewe Rogerson mark.swallow@citigatedr.co.uk
Knut Ekern +47 22 04 82 00
Gambit Hill & Knowlton knut.ekern@hkstrategies.com
US investor enquiries:
Tricia Swanson +1 646 378 2953
The Trout Group tswanson@troutgroup.com

About Algeta

Algeta is a company focused on developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform. The Company is headquartered in Oslo, Norway, and has a US subsidiary, Algeta US, LLC, based in Cambridge, MA performing commercial marketing operations in the US. Algeta is listed on the Oslo Stock Exchange (Ticker: ALGETA). For more information please visit www.algeta.com.

 

Forward-looking Statements

 

This news release contains certain forward-looking statements that are based on uncertainty, as they relate to events and depend on circumstances that will occur in the future and which, by their nature, may have an impact on results of operations and the financial condition of Algeta. Such forward-looking statements reflect our current views and are based on the information currently available to Algeta. Algeta cannot give any assurance as to whether such forward looking statements will prove to be correct. These forward looking statements include statements regarding expected timing of regulatory filings, the build out of our US commercial organization and future development activities.  There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. These factors include, among other things, unforeseen delays in the timing of expected regulatory filings, risks or uncertainties associated with the success of future clinical trials, collaborations with other companies in the development of targeting molecules, the ability to identify and hire a sufficient number of qualified employees for the US field force, growth management, general economic and business conditions and the pricing environment, the impact of competition, the ability to successfully commercialize radium-223 and our other products, the risk that costs associated with the co-promotion of radium-223 may be greater than anticipated, the risk that research & development will not yield new products that achieve commercial success, manufacturing capacity, the risk of non-approval of patents not yet granted, risks in obtaining regulatory approvals for radium-223 and our other products and difficulties of obtaining relevant governmental approvals for new products, and the other risks and uncertainties described in our annual report.




[1] CMC: Chemistry, Manufacturing and Controls

[2] Defined as the sum of External R&D expenses, Payroll and related costs, Depreciation and General and Administrative expenses, and excludes net loss from co-promotion while including some US overhead costs






This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients.

The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of the
information contained therein.

Source: Algeta ASA via Thomson Reuters ONE

HUG#1658158

 

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